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Feasibility of Auricular Acupressure for Appetite and Weight in Patients With Stage II-IV Gastric, Esophageal, and Pancreatic Cancer

Primary Purpose

Clinical Stage II Esophageal Adenocarcinoma AJCC v8, Clinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8, Clinical Stage II Gastric Cancer AJCC v8

Status

Not yet recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Acupressure Therapy

Best Practice

Biospecimen Collection

Questionnaire Administration

About this trial

This is an interventional supportive care trial for Clinical Stage II Esophageal Adenocarcinoma AJCC v8

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 18-65 years of age Stage II-IV gastric, esophageal, or pancreatic cancer Appetite score on visual analog scale =< 70/100 Functional Assessment for Anorexia/Cachexia Treatment Subscale (FACT-ACS) score < 37 At least 60 days of planned systemic treatment, whether already initiated or scheduled to be initiated Access to phone and electronic device for study contacts and questionnaires Willing and able to attend 4 in-person auricular acupressure treatments at the Fred Hutch South Lake Union Clinic Willing and able to perform 4 at-home self-applied treatments of auricular acupressure Participants must not have received acupressure or acupuncture for low appetite within last 30 days Participants must not be actively using corticosteroids or immunomodulators for appetite stimulation at baseline Participants must be able to intake food orally and not require sole or supplemental intravenous nutrition at baseline Participants must not have a history of physiological eating disorders (e.g., anorexia nervosa) in the last 3 years Participants must not have a current known or diagnosed immunodeficiency Participants must have an intact auricular pinna Able to understand and willing to sign written informed consent in English

Sites / Locations

Fred Hutch/University of Washington Cancer Consortium

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I (acupressure therapy)

Arm II (usual care)

Arm Description

Patients undergo auricular acupressure in addition to their usual care on study. Patients also undergo collection of blood samples on study.

Patients receive usual care on study. Patients also undergo collection of blood samples on study.

Outcomes

Primary Outcome Measures

Accrual (feasibility)

Accrual will be measured by the average rate of participants-per-month enrolled into both groups with the goal of 5 patients/month over a 15-month period.

Retention (feasibility)

Retention will be measured by the number of participants who remain in the trial and provide data at the closeout visit.

Intervention adherence (feasibility)

Adherence will be measured in the intervention group by the number of applied auricular acupressure treatments, with the total possible being 8.

Intervention fidelity (feasibility)

Fidelity will be assessed by study team adherence to symptom query and appropriate ear seed point modifications to the standard protocol and accuracy of seed placement according to photographic analysis.

Acceptability (feasibility)

Acceptability will be assessed using a random convenience sample of participants and providers through semi-structured interviews.

Secondary Outcome Measures

Change in appetite

As measured by the Functional Assessment for Anorexia/Cachexia Treatment Subscale. Analyses will assess change in each outcome as a change from baseline to week 4.

Change in appetite

As measured by the Functional Assessment for Anorexia/Cachexia Treatment Subscale. Analyses will assess change in each outcome as a change from baseline to week 8.

Change in body weight (kg)

Analyses will assess change in each outcome as a change from baseline to week 4.

Change in body weight (kg)

Analyses will assess change in each outcome as a change from baseline to week 8.

Full Information

NCT ID

NCT05911243

First Posted

June 12, 2023

Last Updated

June 27, 2023

Sponsor

University of Washington

Collaborators

National Center for Complementary and Integrative Health (NCCIH), National Center for Advancing Translational Sciences (NCATS)

1. Study Identification

Unique Protocol Identification Number

NCT05911243

Brief Title

Feasibility of Auricular Acupressure for Appetite and Weight in Patients With Stage II-IV Gastric, Esophageal, and Pancreatic Cancer

Official Title

A Randomized Controlled Trial Testing the Effects of an Acupressure Intervention on Appetite and Weight in Patients With Gastric, Esophageal, and Pancreatic Cancer: A Pilot and Feasibility Study

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

November 1, 2023 (Anticipated)

Primary Completion Date

November 30, 2024 (Anticipated)

Study Completion Date

January 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Washington

Collaborators

National Center for Complementary and Integrative Health (NCCIH), National Center for Advancing Translational Sciences (NCATS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This clinical trial evaluates the feasibility and acceptability of acupressure to the ear (auricular) to address appetite and weight in patients with stage II-IV gastric, esophageal, or pancreatic cancer. Cancer anorexia, the abnormal loss of appetite, directly leads to cancer-associated weight loss (cachexia) through malnourishment, reduced caloric intake, treatment side-effects, and other modifiable risk factors. Cachexia prolongs length of hospital stay for patients, negatively impacts treatment tolerance and adherence, and reduces overall patient quality of life. Auricular acupressure is a form of micro-acupuncture that exerts its effect by stimulating the central nervous system using adhesive taped pellets applied to specific locations on the external ear. The use of these pellets to deliver auricular acupressure has been shown to improve pain, fatigue, insomnia, nausea and vomiting, depression, and quality of life in both cancer and non-cancer settings. Auricular acupressure is a safe, inexpensive, and non-invasive approach to addressing cancer-related symptoms and treatment side-effects and may be effective at improving appetite and weight loss in stage II-IV gastric, esophageal, and pancreatic cancer patients.

Detailed Description

OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo auricular acupressure in addition to their usual care on study. Patients also undergo collection of blood samples on study. ARM II: Patients receive usual care on study. Patients also undergo collection of blood samples on study. After completion of study treatment, patients in Arm II are followed up at 8 weeks after active treatment ends.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Clinical Stage II Esophageal Adenocarcinoma AJCC v8, Clinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8, Clinical Stage II Gastric Cancer AJCC v8, Clinical Stage III Esophageal Adenocarcinoma AJCC v8, Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8, Clinical Stage III Gastric Cancer AJCC v8, Clinical Stage IV Esophageal Adenocarcinoma AJCC v8, Clinical Stage IV Esophageal Squamous Cell Carcinoma AJCC v8, Clinical Stage IV Gastric Cancer AJCC v8, Stage II Pancreatic Cancer AJCC v8, Stage III Pancreatic Cancer AJCC v8, Stage IV Pancreatic Cancer AJCC v8

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm I (acupressure therapy)

Arm Type

Experimental

Arm Description

Patients undergo auricular acupressure in addition to their usual care on study. Patients also undergo collection of blood samples on study.

Arm Title

Arm II (usual care)

Arm Type

Active Comparator

Arm Description

Patients receive usual care on study. Patients also undergo collection of blood samples on study.

Intervention Type

Procedure

Intervention Name(s)

Acupressure Therapy

Other Intervention Name(s)

Acupressure, Ischemic Compression

Intervention Description

Undergo auricular acupressure

Intervention Type

Other

Intervention Name(s)

Best Practice

Other Intervention Name(s)

standard of care, standard therapy

Intervention Description

Receive usual care

Intervention Type

Procedure

Intervention Name(s)

Biospecimen Collection

Other Intervention Name(s)

Biological Sample Collection, Biospecimen Collected, Specimen Collection

Intervention Description

Undergo collection of blood samples

Intervention Type

Other

Intervention Name(s)

Questionnaire Administration

Other Intervention Name(s)

Quality of Life Assessment

Intervention Description

Ancillary studies

Primary Outcome Measure Information:

Title

Accrual (feasibility)

Description

Accrual will be measured by the average rate of participants-per-month enrolled into both groups with the goal of 5 patients/month over a 15-month period.

Time Frame

Up to 15 months

Title

Retention (feasibility)

Description

Retention will be measured by the number of participants who remain in the trial and provide data at the closeout visit.

Time Frame

Up to 8 weeks

Title

Intervention adherence (feasibility)

Description

Adherence will be measured in the intervention group by the number of applied auricular acupressure treatments, with the total possible being 8.

Time Frame

Up to 8 weeks

Title

Intervention fidelity (feasibility)

Description

Time Frame

Up to 8 weeks

Title

Acceptability (feasibility)

Description

Acceptability will be assessed using a random convenience sample of participants and providers through semi-structured interviews.

Time Frame

Up to 16 weeks

Secondary Outcome Measure Information:

Title

Change in appetite

Description

As measured by the Functional Assessment for Anorexia/Cachexia Treatment Subscale. Analyses will assess change in each outcome as a change from baseline to week 4.

Time Frame

Baseline to week 4

Title

Change in appetite

Description

As measured by the Functional Assessment for Anorexia/Cachexia Treatment Subscale. Analyses will assess change in each outcome as a change from baseline to week 8.

Time Frame

Baseline to week 8

Title

Change in body weight (kg)

Description

Analyses will assess change in each outcome as a change from baseline to week 4.

Time Frame

Baseline to week 4

Title

Change in body weight (kg)

Description

Analyses will assess change in each outcome as a change from baseline to week 8.

Time Frame

Baseline to week 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Blake Langley

Phone

206-667-3481

blangley@fredhutch.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Blake Langley

Organizational Affiliation

Fred Hutch/University of Washington Cancer Consortium

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fred Hutch/University of Washington Cancer Consortium

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Blake Langley

Phone

206-667-3481

blangley@fredhutch.org

First Name & Middle Initial & Last Name & Degree

Blake Langley

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Individual participant data that underlie the results reported in published articles after de-identification may be made available upon request (text, tables, figures, and appendices).

IPD Sharing Time Frame

Beginning 6 months and ending 36 months after publication of results or study protocol, as requested.

IPD Sharing Access Criteria

Researchers and investigators who: 1) provide a methodologically sound proposal to expand on aims in the original, approved proposal; and/or 2) aim to conduct individual, participant-level meta-analyses. Proposals should be directed to blangley@fredhutch.org. To gain access, data requestors will need to sign a data access agreement.

Learn more about this trial

Feasibility of Auricular Acupressure for Appetite and Weight in Patients With Stage II-IV Gastric, Esophageal, and Pancreatic Cancer

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